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Sources: EU EUDAMED, US FDA
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SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
FDA Enforcement
Class II
·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·November 13, 2024
RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
FDA Enforcement
Class II
·Ongoing·Eizo Corporation·June 17, 2020
Shimadzu, Trinias, Digital Angiography System
FDA Enforcement
Class II
·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·March 20, 2024
Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
FDA Enforcement
Class II
·Terminated·Atom Medical Corporation·July 18, 2012
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
FDA Enforcement
Class II
·Terminated·Sysmex Corporation·June 22, 2016
SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FDA Enforcement
Class II
·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016
SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
FDA Enforcement
Class II
·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016
MATSUDA EYEWEAR JAPAN LLC
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·575 Devices·1 Importer
Matsuda
Device
EU MDR
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Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries
Matsuda
Device
EU MDR
·
Eu Md Class 1
·MATSUDA EYEWEAR JAPAN LLC·On the market·29 countries